Comparing long-term and short-term hormone therapy with radiation for prostate cancer
A Randomized, Multicenter, Prospective Phase II Trial to Assess the Effect of Short- Versus Long-term Adjuvant ADT With High Dose Salvage Radiotherapy on Distant Metastasis Free Survival in Patients With Biochemical Relapse After Radical Prostatectomy
This study is testing whether long-term or short-term hormone therapy combined with radiation helps men with prostate cancer who have had surgery and are experiencing a return of the disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 394 (estimated) |
| Sex | Male |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Ghent and 2 other locations) |
| Trial ID | NCT04242017 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of long-term versus short-term adjuvant androgen deprivation therapy (ADT) combined with high-dose salvage radiotherapy in patients who experience biochemical relapse after radical prostatectomy for prostate cancer. It is a randomized, multicenter, prospective trial that focuses on node-negative patients with specific adverse pathological features. The study will assess the impact of these treatment durations on distant metastasis-free survival, providing insights into optimal management strategies for this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are men with a history of histologically proven prostate cancer who have undergone radical prostatectomy and extended pelvic lymph node dissection, and are experiencing an asymptomatic rise in PSA levels.
Not a fit: Patients with distant metastasis or those who do not meet the specific inclusion criteria, such as having a PSA level above 0.4 ng/ml, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival outcomes for prostate cancer patients experiencing biochemical relapse.
How similar studies have performed: Previous studies have explored similar treatment approaches, but this trial specifically addresses the duration of ADT in conjunction with salvage radiotherapy in a node-negative population, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of histologically proven prostate cancer, treated with RP and ePLND. All patients have to be pN0. The minimal template for ePLND is defined as the removal of the external iliac, internal iliac and obturator nodes (standard template). Removal of the presacral and common iliac nodes is left at the discretion of the treating urologist. * Asymptomatic PSA-rise post-RP, defined as a value equal to or more than 0.2µg/l and at least confirmed once (interval ≥2 weeks, confirmation PSA level should be higher). In case of Gleason 8-10, pT3b or R1 resection, an asymptomatic PSA-rise post-RP starting from ≥0.15 µg/l is allowed for inclusion. If the PSA-level is less than 0.4 ng/ml, no additional staging for distant metastasis is required before inclusion in the trial. The patient will be offered the opportunity to participate in a diagnostic sub-study with investigational imaging with 18F PSMA PET CT. However in case of PSA-level \>0.4 ng/ml, biological imaging using 18F-PSMA or 68Ga-PSMA is mandatory as this is not considered investigational anymore. Therefore the patient cannot anymore take part in the diagnostic sub-study and (un-blinded) PET-CT is obligatory to rule out lymph node (N) and /or distant metastasis (M1a-c) before inclusion. * Testosterone levels within above 150 ng/dl. * ECOG 0-1 * Life expectancy more than 5 years * Signed informed consent Exclusion Criteria: * Presence of pN1 disease at original surgical specimen. * Presence of distant metastasis at time of referral (M1a-c). If PSA more than 0.4 ng/ml, imaging with PET-CT is required to rule out distant metastasis (see above). Other additional imaging modalities (CT scan, bone scintigraphy...) are allowed but left at the discretion of the treating centre. * Undetectable PSA (less than 0.2 ng/ml) at time of referral. * Previous RT making new RT impossible (overlapping treatment fields). * Known contraindications to irradiation (Ulcerative Colitis, Crohn Disease, Ataxia Teleangiectasia…) * Active treatment with ADT or PSA modulating drugs (finasteride, dutasteride, high-dose corticoids…) * Not able understanding treatment protocol or signing informed consent.
Where this trial is running
Ghent and 2 other locations
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
- UZ Gent — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Charlien Berghen, MD
- Email: charlien.berghen@uzleuven.be
- Phone: 003216345217
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.